CE Marking | When do EU Directives Apply
Updated: Jun 20, 2022
This Guide is part 1 of a number of guides which will be released weekly and discusses non-food and non-agricultural products referred to as industrial products or products whether for use by consumers or professionals. The product-related legislation that deals with these products will be referred to throughout the text indistinctly as EU Directives.
This guidance is intended to apply to goods which require CE Marking. However,
you should also check the individual EU Directives' scope to see if it's applicable to your goods, and take note of your role as an ‘economic operators’ (i.e. manufacturers, importers,
distributors, and authorised representatives)
See guide part 2 next week on ‘economic operators’
You should note that this guidance represents the CE Marking Authority's interpretation of the legislative framework and does not have legal force.
It's quite easy to establish if an EU Directive applies to your product, by first reading the scope of the directive and seeing if your product falls within the scope of the directive. Warning; when reading the scope do not add anything to it or take anything away basically read what you see and say what you read.
So, if you make an electrical/electronic or mechanical product from a simple toy to a mining machine the product you make will fall within the scope of one of the EU Directives
List of EU Directives:
Please find below a list of the CE Marking Directives and Regulations (European Union directives/regulations that require the affixing of a CE mark to the products covers by them):
· Machinery Directive – 2006/42/EC
· Low Voltage Directive – 2014/35/EU
· EMC Directive – 2014/30/EU
· Medical Devices Directive – 93/42/EEC
· Personal Protective Equipment Directive – 89/686/EEC (as of 21 April 2018 replaced by the Personal Protective Equipment Regulation (Regulation (EU) 2016/425)
· Construction Products Regulation – Regulation (EU) No 305/2011
· Pressure Equipment Directive – 2014/68/EU
· REACH – Regulation (EC) No 1907/2006
· RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
· Waste Electrical and Electronic Equipment Directive – 2012/19/EU
· ATEX Directive – 2014/34/EU
· Toy Directive – 2009/48/EU
· Radio Equipment Directive – 2014/53/EU
· Recreational Craft Directive – 2013/53/EU
· Active Implantable Medical Devices Directive – 90/385/EEC
· Explosive for Civil Use Directive – 93/15/EEC
· Noise Emission in the Environment Directive – 2000/14/EC
· Gas Appliances Directive – 2009/142/EC
· Lifts Directive – 2014/33/EU
· Pyrotechnic Directive – 2007/23/EC
· Measuring Instruments Directive – 2004/22/EC
When to apply EU Directives
EU Directives apply to products which are intended to be placed on the market or put into service and to any subsequent making available until the product reaches the end-user. A product still in the distribution chain falls under the obligations of the EU Directives as long as it is a new product. Once it reaches the end-user it is no longer considered a new product and the EU Directives no longer apply. The end-user is not one of the economic operators who bear responsibilities under EU Directives i.e. any operation or transaction by the end-user involving the product is not subject to EU Directives However, such an operation or transaction might fall under another regulatory regime, in particular at the national level.
The product must comply with the legal requirements that were in place at the time of its placing on the market or putting into service.
EU Directives apply to all forms of supply, including distance selling and selling through electronic means. Hence, regardless of the selling technique products intended to be made available on the EU market must be in conformity with the applicable legislation.
A product intended to be placed on the Union market, offered in a catalogue or by means of electronic commerce, has to comply with EU Directives when the catalogue or website directs its offer to the EU market and includes an ordering and shipping system. Where a product is not intended for the EU market or is not compliant with the applicable EU Directives, this has to be clearly indicated (e.g. by providing a visual warning).
EU Directives apply to newly manufactured products but also to used and second-hand products, including products resulting from the preparation for re-use of electrical or electronic waste, imported from a third country when they enter the EU market for the first time. This applies even to used and second-hand products imported from a third country that were manufactured before the legislation became applicable
EU Directives apply to finished products. Yet, the concept of product varies between different pieces of EU legislation. The objects covered by legislation are referred to, for instance, as products, equipment, apparatus, devices, appliances, instruments, materials, assemblies, components or safety components, units, fittings, accessories, systems or partly completed machinery. Thus, within the terms of a specific EU Directive, components, spare parts or sub-assemblies may be regarded as finished products and their end-use may be the assembly or incorporation into a finished product. It is the responsibility of the manufacturer to verify whether or not the product is within the scope of a given piece of EU Directives
A combination of products and parts, which each comply with applicable legislation, does not always constitute a finished product that has to comply itself as a whole with a given EU Directives. However, in some cases, a combination of different products and parts designed or put together by the same person is considered as one finished product which has to comply with the legislation as such. In particular, the manufacturer of the combination is responsible for selecting suitable products to make up the combination, for putting the combination together in such a way that it complies with the provisions of the laws concerned, and for fulfilling all the requirements of the legislation in relation to the assembly, the EU Declaration of Conformity and CE marking. The fact that components or parts are CE marked does not automatically guarantee that the finished product also complies. Manufacturers must choose components and parts in such a way that the finished product itself complies. The manufacturer must verify on a case-by-case basis whether a combination of products and parts has to be considered as one finished product in relation to the scope of the relevant legislation.
A product, which has been subject to important changes or overhaul aiming to modify its original performance, purpose or type after it has been put into service, having a significant impact on its compliance with EU Directives, must be considered as a new product. This has to be assessed on a case-by-case basis and, in particular, in view of the objective of the legislation and the type of products covered by the legislation in question. Where a rebuilt or modified product is considered as a new product, it must comply with the provisions of the applicable legislation when it is made available or put into service. This has to be verified by applying the appropriate conformity assessment procedure laid down by the legislation in question. In particular, if the risk assessment leads to the conclusion that the nature of the hazard has changed or the level of risk has increased, then the modified product has to be considered as a new product i.e. compliance of the modified product with the applicable essential requirements has to be reassessed and the person carrying out the modification has to fulfil the same requirements as an original manufacturer, for example, preparation of the technical documentation, drawing up an EU declaration of conformity and affixing the CE marking on the product.
In any case, a modified product sold under the name or trademark of a natural or legal person different from the original manufacturer should be considered as new and subject to EU Directives. The person who carries out important changes to the product carries the responsibility for verifying whether or not it should be considered as a new product in relation to the relevant EU Directives. If the product is to be considered as new, this person becomes the manufacturer with the corresponding obligations. Furthermore, in the case the conclusion is that it is a new product, the product has to undergo a full conformity assessment before it is made available on the market. However, the technical documentation has to be updated in as much as the modification has an impact on the requirements of the applicable legislation. It is not necessary to repeat tests and produce new documentation in relation to aspects not impacted by the modification, as long as the manufacturer has copies (or access to copies) of the original test reports for the unchanged aspects. It is up to the natural or legal person who carries out changes or has changes carried out to the product to demonstrate that not all elements of the technical documentation need to be updated.
If you require CE Marking assistance contact the team on the link below